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    Clinical Trial Results:
    A study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative lymphatic imaging and sentinel lymph node identification during standard surgical resection for colonic cancer

    Summary
    EudraCT number
    		 2012-000424-18
    Trial protocol
    		 GB  
    Global end of trial date
    26 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2016
    First version publication date
    20 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICTUC/32/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Room 215 Level 2, Medical School Building Norfolk Place, London, United Kingdom, W2 1PG
    Public contact
    Professor Robin Kennedy, St Marks Hospital - North West London Hospitals NHS Trust, 44 20 8235 4055, robin.kennedy@nhs.net
    Scientific contact
    Professor Robin Kennedy, St Marks Hospital - North West London Hospitals NHS Trust, 44 20 8235 4055, robin.kennedy@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish whether it is possible to identify the first order draining mesocolic lymph nodes (sentinel lymph node(s) (SLNs) in patients with suspected T1 and T2 colonic cancer, using ICG, a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system.
    Protection of trial subjects
    During protocol development two main areas of risk were identified as requiring specific inclusion/exclusion criteria: 1. Risk of allergic (analphylactic or anaphylactoid) reaction which is deemed to be less than 1 in 10. This risk was highlighted in the protocol and all participants were asked about any prior exposure to the agent or reaction to iodine dyes and shellfish. In addition patient’s notes were thoroughly reviewed by a member of the research team as part of the patient’s eligibility assessment. 2. Adverse effects of pregnancy. A pregnancy test was performed in all women of childbearing potential as part of the assessment for eligibility and those who tested positive were excluded from the trial. In addition a risk of colonic perforation (1/2000) related to the endoscopy procedure was highlighted. The procedure, was essential in order to inject the tracer agent and therefore the risk was minimized by effective bowel preparation and ensuring that this examination was performed by an experienced endoscopist. Finally it was stated the study will add 30 minutes to the total operative time. This was considered acceptable by the senior members of the investigative team and would have minimal risk to the patient. An independent, combined Trial Steering Committee/Data Monitoring Committee was convened to oversee the trial.
    Background therapy
    		 There were no protocol-specified background therapies. Concomitant medications could be prescribed at the treating physicians discretion, with the exception of prohibited medications described in the study protocol. Concomitant medications (and the reason for the medication) were recorded in the study database for the period 4-weeks prior to starting study treatment until the patient's last study visit.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    16
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study recruited all 30 patients in one UK site. This site opened to recruitment on 26/06/2016 and the first and last patient consent was on 30/08/2013 and 10/09/2015 respectively.

    Pre-assignment
    Screening details
    		 In total 145 patients were screened for the study, 111 were excluded on inclusion / exclusion criteria. The remaining 34 were approached to participate. Of those 34, 4 patients declined and 30 patients were consented to the study. Each patient consented met all inclusion and no exclusion criteria and was therefore enrolled onto the trial.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Arm title
    		 Interventional Arm
    Arm description
    		 There is only 1 arm in this study. All patients were in the interventional arm and received indocyanine green dye during their surgery so lymphatic imaging and sentinel lymph node identification could be performed as defined in the protocol.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine Green
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Submucosal use
    Dosage and administration details
    5 ml of the mapping agent (ICG) were injected endoscopically into the submucosa in three / four points around the tumour

    Number of subjects in period 1
    		Interventional Arm
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 16 16
    Ethnicity
    Units: Subjects
        White
    		 19 19
        Mixed
    		 0 0
        Asian
    		 6 6
        Black
    		 3 3
        Other
    		 2 2
    Tumour Location
    Units: Subjects
        Caecum
    		 7 7
        Ascending colon
    		 4 4
        Hepatic flexure
    		 1 1
        Transverse
    		 1 1
        Splenic flexure
    		 2 2
        Descending colon
    		 1 1
        Sigmoid
    		 11 11
        Rectosigmoid junction
    		 3 3
    Operation Performed
    Units: Subjects
        Right hemicolectomy
    		 12 12
        Transverse Colectomy
    		 0 0
        High Anterior Resection
    		 13 13
        Left Hemicolectomy
    		 2 2
        Total Colectomy
    		 1 1
        Extended Right Hemicolectomy
    		 1 1
        Other
    		 1 1
    Primary Tumour Size
    Units: Subjects
        T1
    		 6 6
        T2
    		 8 8
        T3
    		 14 14
        T4
    		 2 2
        Non-Malignant
    		 0 0
    Nodal Status
    Units: Subjects
        N0
    		 20 20
        N1
    		 10 10
        N2
    		 0 0
        N3
    		 0 0
        NX
    		 0 0
    Primary Cancer
    Units: Subjects
        Stage A
    		 13 13
        Stage B
    		 7 7
        Stage C1
    		 10 10
        Stage C2
    		 0 0
    Primary Tumour Grade
    Units: Subjects
        G1
    		 4 4
        G2
    		 24 24
        G3/4
    		 2 2
        Unknown
    		 0 0
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27 ( 4 ) -
    Subject analysis sets

    Subject analysis set title
    T1/T2 Colon Cancer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with stage T1/T2 colon cancer at baseline

    Subject analysis sets values
    		 T1/T2 Colon Cancer
    Number of subjects
    14
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.1 ( 10.4 )
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    7
    Ethnicity
    Units: Subjects
        White
    9
        Mixed
    0
        Asian
    4
        Black
    1
        Other
    0
    Tumour Location
    Units: Subjects
        Caecum
    2
        Ascending colon
    2
        Hepatic flexure
    0
        Transverse
    0
        Splenic flexure
    1
        Descending colon
    1
        Sigmoid
    6
        Rectosigmoid junction
    2
    Operation Performed
    Units: Subjects
        Right hemicolectomy
    4
        Transverse Colectomy
    0
        High Anterior Resection
    8
        Left Hemicolectomy
    1
        Total Colectomy
    0
        Extended Right Hemicolectomy
    0
        Other
    1
    Primary Tumour Size
    Units: Subjects
        T1
    6
        T2
    8
        T3
    0
        T4
    0
        Non-Malignant
    0
    Nodal Status
    Units: Subjects
        N0
    12
        N1
    2
        N2
    0
        N3
    0
        NX
    0
    Primary Cancer
    Units: Subjects
        Stage A
    12
        Stage B
    0
        Stage C1
    2
        Stage C2
    0
    Primary Tumour Grade
    Units: Subjects
        G1
    3
        G2
    11
        G3/4
    0
        Unknown
    0
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.1 ( 4.7 )

    End points

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    End points reporting groups
    Reporting group title
    Interventional Arm
    Reporting group description
    		 There is only 1 arm in this study. All patients were in the interventional arm and received indocyanine green dye during their surgery so lymphatic imaging and sentinel lymph node identification could be performed as defined in the protocol.

    Subject analysis set title
    T1/T2 Colon Cancer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with stage T1/T2 colon cancer at baseline

    Primary: Average number of sentinel lymph nodes identified for patients where sentinel lymph nodes were identified

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    End point title
    		 Average number of sentinel lymph nodes identified for patients where sentinel lymph nodes were identified [1]
    End point description
    End point type
    Primary
    End point timeframe
    Average number of sentinel lymph nodes identified for patients where sentinel lymph nodes were identified. This analysis was completed when the last patient had completed the trial.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary analysis was performed using a univariate methods. This method does not have an associated p-value. The EudraCT system would not allow statistical analysis details to be completed without entry of a p-value, however, this does not exist for this data set. Therefore we are unable to add statistical analysis details due to operational errors with the database.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: Number of Sentinel Lymph Nodes
    arithmetic mean (standard deviation)
        Number of sentinel lymph nodes identified
    2.9 ( 1.7 )
    2.6 ( 1.3 )
    No statistical analyses for this end point

    Primary: Average time to identification of lymphatic vessels in minutes

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    End point title
    		 Average time to identification of lymphatic vessels in minutes [2]
    End point description
    End point type
    Primary
    End point timeframe
    Average time to identification of lymphatic vessels in minutes. This analysis was performed when the last patient had completed the trial.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary analysis was performed using a univariate methods. This method does not have an associated p-value. The EudraCT system would not allow statistical analysis details to be completed without entry of a p-value, however, this does not exist for this data set. Therefore we are unable to add statistical analysis details due to operational errors with the database.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: Minutes
    arithmetic mean (standard deviation)
        Time to Identification (Lymphatic Vessels)
    5.4 ( 2.6 )
    5.4 ( 1.8 )
    No statistical analyses for this end point

    Primary: Average time to Identification of lymph nodes

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    End point title
    		 Average time to Identification of lymph nodes [3]
    End point description
    End point type
    Primary
    End point timeframe
    Average time to Identification of lymph nodes. This analysis was completed when the last patient completed the trial.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary analysis was performed using a univariate methods. This method does not have an associated p-value. The EudraCT system would not allow statistical analysis details to be completed without entry of a p-value, however, this does not exist for this data set. Therefore we are unable to add statistical analysis details due to operational errors with the database.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: Minutes
    arithmetic mean (standard deviation)
        Time to identification (lymph nodes)
    7.4 ( 3.5 )
    7.4 ( 2.7 )
    No statistical analyses for this end point

    Primary: Number of patients with aberrant nodal drainage.

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    End point title
    		 Number of patients with aberrant nodal drainage. [4]
    End point description
    End point type
    Primary
    End point timeframe
    Number of patients with aberrant nodal drainage. This analysis was performed when the last patient had completed the trial.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary analysis was performed using a univariate methods. This method does not have an associated p-value. The EudraCT system would not allow statistical analysis details to be completed without entry of a p-value, however, this does not exist for this data set. Therefore we are unable to add statistical analysis details due to operational errors with the database.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: Number of Patients
    number (confidence interval 95%)
        Aberrant nodal drainage
    0 (0 to 12)
    0 (0 to 23)
    No statistical analyses for this end point

    Primary: Number of patients in which sentinel lymph nodes were identified

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    End point title
    		 Number of patients in which sentinel lymph nodes were identified [5]
    End point description
    End point type
    Primary
    End point timeframe
    Number of patients in which sentinel lymph nodes were identified as assessed when the last patient had completed the study.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary analysis was performed using a univariate methods. This method does not have an associated p-value. The EudraCT system would not allow statistical analysis details to be completed without entry of a p-value, however, this does not exist for this data set. Therefore we are unable to add statistical analysis details due to operational errors with the database.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: percent
    number (confidence interval 95%)
        Sentinel Lymph Nodes Identified
    90 (73 to 98)
    93 (66 to 100)
    No statistical analyses for this end point

    Secondary: Sensitivity of sentinel node findings

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    End point title
    		 Sensitivity of sentinel node findings
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed after the last patient had completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30 [6]
    14 [7]
    Units: percent
    number (confidence interval 95%)
        Sensitivity of sentinel node findings
    30 (7 to 65)
    0 (0 to 84)
    Notes
    [6] - Diagnostic test results include 3 patients with no SLNs identified. Patients assumed to be negative.
    [7] - Diagnostic test results include 1 patient with no SLNs identified. Patient assumed to be negative.
    No statistical analyses for this end point

    Secondary: Specificity of sentinel node findings

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    End point title
    		 Specificity of sentinel node findings
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed when the last patient completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30 [8]
    14 [9]
    Units: percent
    number (confidence interval 95%)
        specificity of sentinel node findings
    100 (83 to 100)
    100 (74 to 100)
    Notes
    [8] - Diagnostic test results include 3 patients with no SLNs identified. Patients assumed to be negative.
    [9] - Diagnostic test results include 1 patient with no SLNs identified. Patient assumed to be negative.
    No statistical analyses for this end point

    Secondary: Positive predictive value of sentinel node findings

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    End point title
    		 Positive predictive value of sentinel node findings
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed when the last patient completed the study.
    End point values
    		 Interventional Arm
    Number of subjects analysed
    30 [10]
    Units: percent
    number (confidence interval 95%)
        positive predictive value of sentinel node finding
    100 (29 to 100)
    Notes
    [10] - Diagnostic test include 3 patients with no SLN identified. Patients assumed negative
    No statistical analyses for this end point

    Secondary: Negative predictive value of sentinel node findings

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    End point title
    		 Negative predictive value of sentinel node findings
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed when the last patient had completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30 [11]
    14 [12]
    Units: percent
    number (confidence interval 95%)
        Negative predictive value of sentinel node finding
    74 (54 to 89)
    86 (57 to 98)
    Notes
    [11] - Diagnostic test results include 3 patients with no SLNs identified. Patients assumed to be negative.
    [12] - Diagnostic test results include 1 patient with no SLNs identified. Patient assumed to be negative.
    No statistical analyses for this end point

    Secondary: Accuracy of sentinel node findings

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    End point title
    		 Accuracy of sentinel node findings
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed when the last patient has completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30 [13]
    14 [14]
    Units: percent
    number (confidence interval 95%)
        Accuracy of sentinel node findings
    77 (58 to 90)
    86 (57 to 98)
    Notes
    [13] - Diagnostic test results include 3 patients with no SLNs identified. Patients assumed to be negative.
    [14] - Diagnostic test results include 1 patient with no SLNs identified. Patient assumed to be negative.
    No statistical analyses for this end point

    Secondary: Patients with aberrant sentinel nodes

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    End point title
    		 Patients with aberrant sentinel nodes
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed after the last patient had completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: percent
    number (confidence interval 95%)
        Patients with aberrant sentinel nodes
    0 (0 to 12)
    0 (0 to 23)
    No statistical analyses for this end point

    Secondary: Patients with positive aberrant nodes

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    End point title
    		 Patients with positive aberrant nodes
    End point description
    End point type
    Secondary
    End point timeframe
    This analysis was performed after the last patient had completed the study.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: percent
    number (confidence interval 95%)
        Patient with positive aberrant nodes
    0 (0 to 12)
    0 (0 to 23)
    No statistical analyses for this end point

    Secondary: Number of lymph nodes identified per patient

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    End point title
    		 Number of lymph nodes identified per patient
    End point description
    End point type
    Secondary
    End point timeframe
    Average number of lymph nodes identified for patients. This analysis was completed when the last patient had completed the trial.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: Number of Lymph Nodes
    arithmetic mean (standard deviation)
        Number of lymph nodes identified per patient
    33.3 ( 14.3 )
    31.1 ( 13.4 )
    No statistical analyses for this end point

    Secondary: Number of patients with positive nodes

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    End point title
    		 Number of patients with positive nodes
    End point description
    End point type
    Secondary
    End point timeframe
    Percentage of patients with positive nodes. This analysis was completed when the last patient had completed the trial.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: percent
    number (not applicable)
        Number of patients with positive nodes
    33
    14
    No statistical analyses for this end point

    Secondary: Number of patients with positive sentinel nodes

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    End point title
    		 Number of patients with positive sentinel nodes
    End point description
    End point type
    Secondary
    End point timeframe
    Percentage of patients with positive sentinel nodes. This analysis was completed when the last patient had completed the trial.
    End point values
    		 Interventional Arm T1/T2 Colon Cancer
    Number of subjects analysed
    30
    14
    Units: percent
    number (not applicable)
        Number of patients with positive sentinel nodes
    10
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from the time a patient signed informed consent until the end of followup. AEs were followed-up according to local practice until the event has stabilised or resolved, or until the last follow-up visit, whichever was sooner
    Adverse event reporting additional description
    AEs were reviewed at every patient visit. AEs we assessed for severity (NCI CTCAE v4.03) and causality by the local PI; the CI provided an assessment for SAEs. All AEs were recorded in the study EDC system.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Interventional Arm
    Reporting group description
    		 All patients that received at least one dose of the IMP

    Serious adverse events
    		 Interventional Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Interventional Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Postoperative ileus
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Wound Pain
         subjects affected / exposed
    29 / 30 (96.67%)
         occurrences all number
    29
    Vascular disorders
    Blood pressure decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Paroxysmal Atrial Fibrillation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Febrile Reaction
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Rigors
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Abdominal distension
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hiccups
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ileus
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    12 / 30 (40.00%)
         occurrences all number
    12
    Vomiting
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Bloating
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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